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Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial

NCT07064460 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-04

No results posted yet for this study

Summary

The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.

Conditions

  • Aortic Disorders

Interventions

DEVICE

Physician Modified Endovascular Graft

The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery. All components used to create the final device (PMEG), made specifically for each participant and tailored to their individual anatomy, are FDA-approved, although the final graft itself (the PMEG) is considered investigational.

Sponsors & Collaborators

  • Chandler Long, MD

    lead OTHER

Principal Investigators

  • Chandler Long, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2030-12-11
Completion
2031-12-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064460 on ClinicalTrials.gov